Hydralazine Hydrochloride

Product NDC
72162-1538
11-digit product format
721621538
Labeler code
72162
Product ID
72162-1538_377104a7-04fe-4997-82c8-04f54623b6d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205236
Marketing category
ANDA
Marketing start
2017-05-26
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydralazine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDRALAZINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFD171B778Y
Rxcui905222

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3137695-e199-b3b3-2950-87a8ac429689Product name520260316
e9ed2ee5-d109-4795-bffe-c3b047717749Product name220250107
0284f4a6-db58-dacf-18fe-da73f4aeea88Product name420180827
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1538-1Hydralazine Hydrochloride100 in 1 BOTTLETABLET100100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1538-1EA - Each72162-1538c0974795-9d5e-46c7-b317-bc801e4e567b12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1538HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240206_bc37cf50-b18d-467e-bf67-3270faa8332e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905222hydrALAZINE HCl 100 MG Oral TabletPSNbc37cf50-b18d-467e-bf67-3270faa8332e100
905222hydralazine hydrochloride 100 MG Oral TabletSCDbc37cf50-b18d-467e-bf67-3270faa8332e100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1538-172162153801100 TABLET in 1 BOTTLE (72162-1538-1) 100 tablet2024-02-05NoNoHistorical